Transcatheter heart valve storage container and crimping mechanism

ABSTRACT

Disclosed herein is a storage container for an expandable prosthetic heart valve that crimps the valve upon opening the container and removal of the valve from the container. The container includes a housing sized to receive the heart valve in its expanded configuration and a crimping mechanism. The crimping mechanism is incorporated into the container and engages the heart valve so as to operably convert the heart valve from its expanded configuration to its smaller crimped configuration upon opening the container and removing the valve.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/534,033, filed Jul. 18, 2017, which is incorporated by reference inits entirety for all purposes.

TECHNICAL FIELD

The present invention relates generally to medical devices andparticularly to containers and methods for storing and preparingexpandable heart valve prostheses for implantation.

BACKGROUND

Prosthetic heart valves are used to replace damaged or diseased heartvalves. In vertebrate animals, the heart is a hollow muscular organhaving four pumping chambers: the left and right atria and the left andright ventricles, each provided with its own one-way valve. The naturalheart valves are identified as the aortic, mitral (or bicuspid),tricuspid and pulmonary valves. Prosthetic heart valves can be used toreplace any of these naturally occurring valves.

Where replacement of a heart valve is indicated, the dysfunctional valveis typically surgically removed and replaced with either a mechanicalvalve or a tissue valve. Tissue valves are often preferred overmechanical valves because they typically do not require long-termtreatment with anticoagulants. The most common tissue valves areconstructed with whole porcine (pig) valves, or with separate leafletsobtained from bovine (cow) pericardium. Although so-called stentlessvalves, comprising a section of porcine aorta along with the valve, areavailable, the most widely used valves include some form of stent orsynthetic leaflet support. Typically, a wireform having alternatingarcuate cusps and upstanding commissures supports the leaflets withinthe valve, in combination with an annular stent and a sewing ring. Thealternating cusps and commissures mimic the natural contour of leafletattachment.

A conventional heart valve replacement surgery involves accessing theheart in the patient's thoracic cavity through a longitudinal incisionin the chest. For example, a median sternotomy requires cutting throughthe sternum and forcing the two opposing halves of the rib cage to bespread apart, allowing access to the thoracic cavity and heart within.The patient is then placed on cardiopulmonary bypass which involvesstopping the heart to permit access to the internal chambers. Such openheart surgery is particularly invasive and involves a lengthy anddifficult recovery period.

Recently, a great amount of research has been performed to reduce thetrauma and risk associated with conventional open heart valvereplacement surgery. In particular, the field of minimally invasivesurgery (MIS) has exploded since the early to mid-1990s, with devicesnow being available to enable valve replacements without opening thechest cavity. MIS heart valve replacement surgery still typicallyrequires bypass, but the excision of the native valve and implantationof the prosthetic valve are accomplished via elongated tubes (cathetersor cannulas), with the help of endoscopes and other such visualizationtechniques.

More recently, a variety of prosthetic heart valves have been developedwherein the valve structure is mounted on a stent and then delivered tothe implantation site via a percutaneous catheterization technique. Suchtranscatheter heart valves (THV) are typically crimped to a smallerdiameter or profile just prior to implantation.

To minimize the possibility of damage to the relatively delicate tissuetype or bioprosthetic heart valves, they are packaged in jars filledwith a sterilant and preservative solution for shipping and storageprior to use. In doing so, the valves are stabilized to prevent thevalves from contacting the inside of the jar. Prior to implantation in apatient, residual traces of the sterilant and preservative solution arewashed from the valve. Washing is accomplished by first removing thevalve from the jar and then rinsing the valve in a sterile salinesolution. After rinsing, the valve is crimped to reduce it to a sizeappropriate for transcatheter delivery and implantation. This processleaves the valve susceptible to damage if the valve contacts anysurfaces while being manipulated prior to implantation.

There remains a need for a storage and preparation system for suchvalves that prevents damage to the valve, and enables a medicalpractitioner to easily and safely remove the valve from the storagecontainer, prepare, and crimp the valve prior to implantation

SUMMARY

Disclosed herein is a storage container for a transcatheter heart valvethat allows for the storage of the heart valve in its expandedconfiguration and permits easy crimping of the heart valve from a largerdiameter to a smaller diameter upon removal of the valve from thestorage jar prior to implantation. The storage container includes acontainer housing and a crimping mechanism. The container housing issized to receive the heart valve in its expanded configuration. Thecrimping mechanism is incorporated into the container and engages theheart valve to convert the heart valve from its expanded configurationto its crimped or unexpanded configuration upon opening of the containerand removal of the valve.

While the present invention is particularly well-suited for use withstented prosthetic heart valves, it can also be applied to other typesof stents such as coronary stents, peripheral stents, other stentedheart valves and stent grafts.

In some embodiments, the crimping mechanism includes a valve covercoupled to the container housing. The valve cover including a centralopening in communication with an interior of the container housing wheremovement of the heart valve through the central opening converts theheart valve from its expanded configuration to its crimpedconfiguration. The heart valve has a larger diameter in its expandedconfiguration than in its crimped configuration.

The valve cover can include a tapered channel extending from a bottomsurface to the central opening, where movement of the heart valvethrough the tapered channel upon opening of the container converts theheart valve from its expanded configuration to its crimpedconfiguration. In some embodiments, the tapered channel can define acone-shaped passage. The size of the opening to the tapered channel atthe bottom surface of the valve cover can be designed to correspond tothe size of the heart valve in its expanded configuration, while theother end of the channel corresponds to the size of the valve in itscrimped configuration.

In some embodiments, the crimping mechanism further includes a top covercoupled to the container housing having an opening axially aligned withthe central opening of the valve cover. The crimping mechanism furtherincludes a base structure having a central cavity sized and configuredto receive the heart valve. The base is axially movable with respect tothe valve cover for moving the heart valve through the central openingof the valve cover. The valve cover can be fixed to the containerhousing. And the top cover can be rotatably coupled to the containerhousing and the valve cover. The base includes an exterior thread forengaging a threaded opening in the top cover such that rotation of thetop cover causes the threaded opening to engage the exterior threads ofthe base and move the base axially with respect to the top cover.

In some embodiments, the crimping mechanism further includes a valvestage located within a central cavity of the base, the valve stageproviding axial support for the heart valve. In other embodiments, thecrimping mechanism includes a valve support extending axially adjacentthe heart valve and providing radial or lateral support for the heartvalve.

Also disclosed herein is a system for storing and crimping an expandableprosthetic heart valve. The system includes an expandable prostheticheart valve having both crimped and expanded configurations, the heartvalve comprising an annular frame with a leaflet structure positionedwithin frame. The system also includes a container housing sized toreceive the heart valve in its expanded configuration, and a crimpingmechanism incorporated into the container housing and engaging the heartvalve that is operable to convert the heart valve from its expandedconfiguration to its crimped configuration upon opening of the containerand removal of the heart valve. The heart valve can be a tissue-typevalve and the container housing can hold a solution suitable forpreserving the leaflet structure.

In some embodiments, crimping mechanism includes a valve cover coupledto the container housing and including a central opening incommunication with an interior of the container housing, and a basehaving a central cavity sized and configured to receive the heart valve.The base is axially movable with respect to the valve cover for movingthe heart valve through the central opening of the valve cover. Theheart valve is positioned within a central cavity of the base, andmovement of the heart valve through the central opening converts theheart valve from its expanded configuration to its crimpedconfiguration.

In some embodiments, the crimping mechanism includes a top coverrotatably coupled to the valve cover and the container housing, the topcover having an opening axially aligned with the central opening of thevalve cover. The base includes an exterior thread for engaging athreaded opening in the top cover. The base is rotatably coupled to thetop cover and rotation of the top cover causes the threaded opening toengage the exterior threads of the base thereby moving the base axiallywith respect to the top cover.

In some embodiments, the valve cover includes a tapered channelextending from a bottom surface of the valve cover to the centralopening of the valve cover. The size of the opening to the taperedchannel at the bottom surface corresponds to the size of the heart valvein its expanded configuration while the other end of the channelcorresponds to the size of the valve in its crimped configuration.Movement of the heart valve through the tapered channel converts theheart valve from its expanded configuration to its crimpedconfiguration.

Further disclosed herein is a method of storing and crimping anexpandable prosthetic heart valve. The method includes providing aprosthetic heart valve having a crimped configuration sized to bedelivered to a site of implantation through a catheter and an expandedconfiguration sized to engage a heart valve annulus. The method alsoincludes storing the heart valve in a container in its expandedconfiguration and converting the heart valve from its expandedconfiguration to its crimped configuration as it passes through anopening in the container. The step of converting further comprisescompressing the heart valve through a tapered channel provided in thecontainer.

In some embodiments, the container includes a container housing, a valvecover coupled to the container housing and including a central openingin communication with an interior of the container housing, and a basehaving a central cavity receiving the heart valve. The base is rotatablycoupled to the valve cover and axially movable with respect to the valvecover and container housing. The step of converting the heart valve fromits expanded configuration to its crimped configuration furthercomprises axially moving the base with respect to the valve cover andadvancing the heart valve from the central cavity of the base andthrough the central opening of the valve cover.

In some embodiments, a top cover is rotatably coupled to the valve coverand the container housing. The base can include an exterior thread forengaging a threaded opening in the top cover, where the threaded openingin the top cover is axially aligned with the central opening of thevalve cover. The step of converting the heart valve from its expandedconfiguration to its crimped configuration further comprises rotatingthe top cover to cause the threaded opening to engage the exteriorthreads of the base and thereby moving the base axially with respect tothe top cover.

In some embodiments, the step of converting the heart valve from itsexpanded configuration to its crimped configuration further comprisescrimping the heart valve and maintaining the heart valve in its crimpedstate using a constraint around the heart valve. And the method furtherincludes detaching the heart valve from the storage container afterplacing the constraint around the valve and mounting the valve on adelivery catheter.

The details of one or more embodiments of the disclosure are set forthin the accompanying drawings and the description below. Other features,objects, and advantages of the disclosure will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an example storage container for atranscatheter heart valve;

FIG. 2 is a front view of the storage container of FIG. 1;

FIG. 3 is a top view of the storage container of FIG. 1;

FIG. 4 is a bottom view of the storage container of FIG. 1;

FIG. 5 is a perspective view of the storage container of FIG. 1including a lid;

FIG. 6 is a front perspective view of the storage container of FIG. 5;

FIG. 7 is a bottom perspective view of the lid of FIG. 5;

FIG. 8 is a front view of the storage container of FIG. 5;

FIG. 9A is a section view of the storage container of FIG. 1;

FIG. 9B is a section view of the storage container of FIG. 1;

FIG. 10 is a top perspective view of an example valve cover;

FIG. 11 is a bottom perspective view of the valve cover of FIG. 10;

FIG. 12 is a front view of the valve cover of FIG. 10;

FIG. 13 is at top view of the valve cover of FIG. 10;

FIG. 14 is a bottom view of the valve cover of FIG. 10;

FIG. 15 is a section view of the valve cover of FIG. 13;

FIG. 16 is a front view of an example base;

FIG. 17 is a side view of the base of FIG. 16;

FIG. 18 is a perspective view of the base of FIG. 16;

FIG. 19 is a top view of the base of FIG. 16;

FIG. 20 is a bottom view of the base of FIG. 16;

FIG. 21 is a perspective view of an example lower flange;

FIG. 22 is a bottom view of the lower flange of FIG. 21;

FIG. 23 is a perspective view of an example valve stage;

FIG. 24 is a front view of the valve stage of FIG. 23;

FIG. 25 is a top view of the valve stage of FIG. 23;

FIG. 26 is a section view of the valve stage of FIG. 25;

FIG. 27 is a perspective view of an example support ring;

FIG. 28 is a front view of the support ring of FIG. 27;

FIG. 29 is a top view of the support ring of FIG. 27;

FIG. 30 is a perspective view of an example valve support;

FIG. 31 is a front view of the valve support of FIG. 30;

FIG. 32 is a side view of the valve support of FIG. 30;

FIG. 33 is a top view of the valve support of FIG. 30;

FIG. 34 is a perspective view of an example valve support ring;

FIG. 35 is a front view of the valve support ring of FIG. 34; and

FIG. 36 is a top view of the valve support ring of FIG. 34.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

The following description of certain examples of the inventive conceptsshould not be used to limit the scope of the claims. Other examples,features, aspects, embodiments, and advantages will become apparent tothose skilled in the art from the following description. As will berealized, the device and/or methods are capable of other different andobvious aspects, all without departing from the spirit of the inventiveconcepts. Accordingly, the drawings and descriptions should be regardedas illustrative in nature and not restrictive.

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedescribed methods, systems, and apparatus should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The disclosed methods, systems, and apparatus are notlimited to any specific aspect, feature, or combination thereof, nor dothe disclosed methods, systems, and apparatus require that any one ormore specific advantages be present or problems be solved.

Features, integers, characteristics, compounds, chemical moieties, orgroups described in conjunction with a particular aspect, embodiment orexample of the invention are to be understood to be applicable to anyother aspect, embodiment or example described herein unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract, and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The invention is notrestricted to the details of any foregoing embodiments. The inventionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract, and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

As used in the specification and the appended claims, the singular forms“a,” “an” and “the” include plural referents unless the context clearlydictates otherwise. Ranges may be expressed herein as from “about” oneparticular value, and/or to “about” another particular value. When sucha range is expressed, another aspect includes from the one particularvalue and/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another aspect. It will befurther understood that the endpoints of each of the ranges aresignificant both in relation to the other endpoint, and independently ofthe other endpoint.

“Optional” or “optionally” means that the subsequently described eventor circumstance may or may not occur, and that the description includesinstances where said event or circumstance occurs and instances where itdoes not.

Throughout the description and claims of this specification, the word“comprise” and variations of the word, such as “comprising” and“comprises,” means “including but not limited to,” and is not intendedto exclude, for example, other additives, components, integers or steps.“Exemplary” means “an example of” and is not intended to convey anindication of a preferred or ideal aspect. “Such as” is not used in arestrictive sense, but for explanatory purposes.

The terms “proximal” and “distal” as used herein refer to regions of asheath, catheter, or delivery assembly. “Proximal” means that regionclosest to handle of the device, while “distal” means that regionfarthest away from the handle of the device.

The term “tube” or “tubular” as used herein is not meant to limit shapesto circular cross-sections. Instead, tube or tubular can refer to anyelongate structure with a closed-cross section and lumen extendingaxially therethrough. A tube may also have some selectively locatedslits or openings therein—although it still will provide enough of aclosed structure to contain other components within its lumen(s).

Embodiments disclosed herein provide a storage container for atranscatheter heart valve that also facilitates preparation for deliveryand implantation of the valve. Transcatheter heart valves come in avariety of designs, including directly radially expandable types (suchas balloon expandable valves), self-expanding valves, mechanicallyexpandable valves, and so-called “rolled” heart valves that are spirallywound into a compact configuration that can be expanded by unwinding.While a balloon expandable heart valve is represented herein, it shouldbe understood that the principles disclosed herein are applicable to alltypes of expandable heart valves, stents and similar medical devices.

The present disclosure is directed to a container for storing,preparing, and handling an expandable prosthetic heart valve prior toimplantation. Many transcatheter heart valves include flexible leafletstypically made from animal tissue or other biocompatible natural orsynthetic material. The embodiment illustrated represents an expandableprosthetic heart valve having bovine pericardial leaflets. This heartvalve is similar to that shown and described in U.S. Pat. No. 9,393,110,entitled “Prosthetic Heart Valve” and expressly incorporated herein byreference. Regardless of the material of the flexible leaflets, it isadvantageous to store them in a relaxed state to minimize folding orcompression of the leaflets. However, to deliver such expandable heartvalves, the overall profile of the valve is made smaller (i.e., crimped)in order to pass through a relatively small diameter delivery catheter,thus requiring folding or compressing of the leaflets.

The container of the present disclosure enables the storage of a heartvalve in its expanded configuration to better protect the flexibleleaflets during potentially long storage times, and permits easycrimping of the heart valve upon removal from the storage jar prior toimplantation.

FIG. 1 illustrates an assembled view of an example storage container 100for a prosthetic heart valve 105, the valve having both expanded andunexpanded configurations. FIG. 2 provides a front elevation of thestorage container 100, and FIGS. 3 and 4 provide top and bottom views,respectively. As shown, the storage container 100 includes a containerhousing 110 sized to receive the heart valve 105 in its expandedconfiguration (as shown in FIGS. 9A and 9B) and a top cover 130.

The storage container 100 includes a removable lid 190 to preventcontamination of the heart valve 105 and other storage container 100components. FIGS. 5, 6 and 8 illustrate the storage container 100 ofFIG. 1 with the lid 190 coupled to the top cover 130. The lid 190 issized and configured to be removably press fit (interference fit) intothe threaded opening 132 of the top cover 130. FIG. 7 provides a bottomperspective view of the lid 190 illustrating a raised annular surface191 projecting from the bottom of the lid 190 for engaging the threadedopening 132 of the top cover 130 of the storage container 100. It isalso contemplated that the lid 190 can couple to the top cover 130 usinga snap fit, a threaded connection, or using any other reversiblefastener known in the art. The storage container 100 can be used forstoring bioprosthetic heart valves having leaflets that require wetstorage in a liquid sterilant/preservative. Therefore, when the lid 190is coupled to the top cover 130, the storage container 100 is desirablyleak-proof. The various components of the storage container 100 can bemade of a variety of corrosion resistant materials, preferably moldedpolymers.

As will be described in more detail below, a crimping mechanism 120 isincorporated into the container 100. The crimping mechanism 120 engagesthe heart valve 105 and is operable to convert the heart valve 105 froma larger diameter in its expanded configuration to a smaller diameter inits crimped configuration upon opening the container and removal of thevalve from the container 100. FIGS. 9A and 9B provide cross-sectionviews of the storage container 100 of FIG. 1 taken along the sectionlines illustrated in FIG. 3. FIGS. 9A and 9B illustrate the variouscomponents of the crimping mechanism 120 including the top cover 130, abase 140, a valve cover 150, a valve stage 160, and a valve support 170.

FIGS. 10-14 provide various view of an example valve cover 150. FIG. 15provides a cross-section of the valve cover 150 taken along the sectionlines illustrated in FIG. 13. The valve cover 150 includes a centralopening 152 in communication with the interior of the container housing110. As will be described in more detail below, as the heart valve 105is pushed through valve cover 150 and out the central opening 152, it isconverted from its larger expanded configuration to its smallerunexpanded/crimped configuration. The diameter of the central opening152 corresponds to the diameter of the heart valve 105 in the crimpedconfiguration. As illustrated in FIG. 15, the valve cover 150 includes atapered channel 154 extending from a bottom opening 158 on the bottomsurface 156 of the valve cover 150 to the central opening 152. Thetapered channel 154 can define a cone-shaped passage. The taperedchannel 154 can also include a cylindrically-shaped portion 155 adjacentthe central opening 152. This cylindrically-shaped portion 155 can helpmaintain the heart valve 105 in its crimped configuration and in asecure position for attachment to a delivery device. Thedimension/diameter of the opening 158 provided on the bottom surface 156of the valve cover 150 is sized and configured to correspond to thedimension/diameter of the heart valve 105 in the expanded configuration.The opening 158 can also have a dimension/diameter larger than thedimension/diameter of the heart valve 105 in the expanded configuration.

As illustrated in FIGS. 11, 12 and 15, the bottom surface 156 of thevalve cover 150 includes a cylindrically-shaped projection 159. Asprovided in FIGS. 9A and 9B, this projection 159 is sized to extendinto, and help position, the valve cover 150 with respect to thecontainer housing 110.

The valve cover 150 can be fixedly connected to the container housing110 such that the valve cover 150 cannot move axially and/orrotationally with respect to the container housing 110. For example, thevalve cover 150 can be coupled to the container housing 110 by a numberof screws positioned around the circumference of the valve cover 150. Itis contemplated that the valve cover 150 could be coupled to thecontainer housing 110 using any suitable known fastener. As will bedescribed in more detail below, with the valve cover 150 fixed to thecontainer housing 110, rotation of the top cover 130 allows the heartvalve 105 (supported by base 140) to move axially within the storagecontainer 100 and ultimately out through opening 152. As such, the heartvalve 105 is converted from its larger expanded configuration to itssmaller crimped configuration upon removal from the container.

FIGS. 16-20 provide various views of an example base 140. The base 140includes a central cavity 143 sized to receive the heart valve 105, asillustrated in FIGS. 9A and 9B. The base 140 is axially movable withrespect to the valve cover 150 and the top cover 130 for moving theheart valve 105 through the central opening 152 of the valve cover 150.

The base 140 includes an engagement feature for mating with the topcover 130 to facilitate axial movement of the base 140. For example, asillustrated in FIG. 9B, the top cover 130 includes a threaded opening132 axially aligned with the opening 152 of the valve cover 150. Thebase 140 can include an exterior thread 142 for rotatably coupling withthe threaded opening 132 of the top cover 130.

As illustrated in FIG. 9B, a portion of the base 140 extends through thevalve cover 150 to threadingly engage the threaded opening 132 of thetop cover 130. For example, as provided in FIG. 16, the exterior thread142 is provided on one or more arms 144 of the base 140. The arms 144extend up from a generally horizontal end surface 145 of the base 140.In assembly, the arms 144 extend through openings 151 provided in thevalve cover 150 (shown in FIG. 13) to engage the threaded opening 132 ofthe top cover 130. In an example storage container 100, the arms 144 aresized and configured to move freely through the openings 151 in thevalve cover 150 and do not engage or contact the valve cover 150 duringaxial movement of the base 140. FIGS. 13 and 14 of the valve cover 150illustrate example arcuate shaped openings 151 for accommodating throughmovement of the arms 144 of the base 140.

The storage container 100 includes a lower flange 134 for axially fixingthe container housing 110, valve cover 150, and top cover 130. FIGS. 21and 22 provide perspective and top views, respectively, of the lowerflange 134. As provided in FIGS. 9A and 9B, the lower flange 134 iscoupled to a bottom surface 136 of the top cover 130 such that the lowerflange 134 is fixedly connected, axially and rotationally, with respectto the top cover 130. The lower flange 134 can be coupled to the topcover 130 by a number of screws positioned around the circumference ofthe lower flange 134. It is contemplated that the lower flange 143 canbe coupled to the top cover 130 using any suitable fastener known in theart. A recessed shoulder 138 provided on the lower flange 134 can besized to provide a gap or space 139 between the lower flange 134 and thecontainer housing 110 and the valve cover 150. The inclusion of thisgap/spacing 139 allows the top cover 130 and lower flange 143 to rotateindependently of the container housing 110 and valve cover 150 (thecontainer housing 110 being fixedly connected to the valve cover 150).

FIGS. 23-25 provide various views of an example valve stage 160. FIG. 26is a cross-section view of the valve stage 160 taken along the sectionline illustrated in FIG. 25. The valve stage 160 is located within thecentral cavity 143 of the base 140. The heart valve 105 is positioned onthe valve stage 160 such that the valve stage 160 provides axial supportfor the heart valve 105. The valve stage 160 can include multiple arms162 extending up from a base structure 166 of the valve stage 160. Asillustrated in FIGS. 23 and 25, the arms 162 can be equally spacedaround the circumference of the valve stage 160. The top surface 164 ofthe arms 162 provides the support surface for the heart valve 105. Thearms 162 can move radially. That is, the ends of the arms 162 can moveradially in towards the longitudinal axis of the valve stage 160,resulting in a radial compression of the valve stage 160 proximate theend of the arms 162. The arms 162 are fixed to the base structure 166,but flexure features (such as cutouts 161 illustrated in FIG. 26) can beprovided at the juncture between the arms 162 and the base structure166. The arms 162 can also be constructed from a flexible material, toallow them to flex under compressive force (i.e., the force applied bythe tapered channel 154 as the valve stage 160 is moved axially alongwith the base 140). This allows the arms 162 and the distal end of thevalve stage 160 to contract slightly as it is pushed into the taperedchannel 154 during crimping of the heart valve 105. It is alsocontemplated that the valve stage 160 can be used to limit axialmovement of the base 140 and help push the heart valve 105 through thetapered channel 154. For example, as contact between the valve arms 162and the tapered channel 154 causes the arms 162 to move radially inward,the arms 162 will reach a point of ultimate compression therebypreventing any further axial movement of the valve stage 160 and thebase 140. As illustrated in FIGS. 23 and 25, the arms 162 can define awedge-shape in cross-section. This wedge-shape allows the arms 162 tocompress until the adjacent side walls 163A and 163B of the wedge-shapearms 162 contact. The arms 162 can also include a bend 165 along thelength of the arm 162. This bend 165 provides for furthercompression/radial movement of the arms 162.

FIGS. 27-29 provide various views of an example support ring 180. Thecrimping mechanism 120 can include a support ring 180 positioned at thetop surface 164 of the valve stage 160 as illustrated in FIGS. 9A and9B. The support ring 180 helps position the heart valve 105 on the valvestage 160 and within the tapered channel 154. As illustrated in FIGS. 27and 28, the support ring 180 includes a tapered edge 182 that provides acontact point for the heart valve 105 and centers the heart valve 105 onthe support ring 180.

FIGS. 30-33 provide various views of an example valve support 170. Thecrimping mechanism 120 includes a valve support 170 that extends axiallyadjacent to the heart valve 105 as illustrated in FIG. 9A. During axialmovement of the base 140 and/or crimping of the heart valve 105, thevalve support 170 can provide radial and/or lateral support for theheart valve 105. The valve support 170 can include axially extendingarms 172 that extend from a base structure 174. The arms 172 can definea curved inner surface 176 corresponding in size and shape to the outersurface of the heart valve 105.

The valve support 170 remains fixed axially within the container housing110 during crimping of the heart valve 105. That is, as the base 140moves axially towards/away from the top cover 130, the arms 172 of thevalve support 170 extend/pass through openings 146 provided in the base140. In an example storage container 100, the arms 172 are sized andconfigured to move freely through the openings 146 in the base 140.FIGS. 18-20 illustrate arcuate-shaped openings 146 for accommodatingthrough movement of the arms 172. As illustrated in FIG. 9A, the basestructure 174 is positioned under the base 140, and between the base 140and the container housing 110.

FIGS. 34-36 provide various views of an example upper valve support ring185. The crimping mechanism 120 includes an upper valve support ring 185positioned at the lower surface 156 of the valve cover 150 proximate theopening 158 to the tapered channel 154 as illustrated in FIGS. 9A and9B. As shown in FIGS. 30 and 31, the distal end of the arms 172 of thevalve support 170 can include a recessed surface 178 for accommodatingthe upper valve support ring 185. The upper valve support ring 185 canbe positioned above the heart valve 105 and can be used to secure theheart valve 105 in the container 110 in its expanded configuration. Theupper support ring 185 can also be used to guide the heart valve 105into the tapered channel 154 and ease the transition (from the expandedconfiguration) into the valve cover 150 and towards the crimpedconfiguration.

As mentioned above, a preferred heart valve 105 includes a stent bodyand a plurality of flexible leaflets. If the leaflets need to remainhydrated during storage, such as if they are made of bioprostheticmaterial, the entire container housing 110 is filled with a liquidsterilant/preservative solution. To facilitate preparation of the heartvalve 105 prior to implantation, the container housing 110 and/or topcover 130 can include a drain hole (not shown). Alternatively, the lid190 can be removed from the top cover 130 and unwanted fluid can bedrained by tilting or inverting the storage container 100.

Prior to implantation of the heart valve 105, the preservative solution(if present) can be drained from within the container housing 110. Ifdesired, the lid 190 can be removed and the heart valve 105 rinsed whilethe heart valve 105 remains within the container housing 110, therebyreducing the chance of damage to the valve 105. The heart valve 105 canthen be crimped by passing the heart valve 105 through the crimpingmechanism 120. The user can grasp the container housing 110 to hold itin a fixed position whiling rotating the top cover 130. Rotation of thetop cover 130 allows the exterior thread 142 on the arms 144 of the base140 to engage the threaded opening 132 in the top cover 130, resultingin axial movement of the base 140. Axial movement of the base 140results in a corresponding axial movement of the heart valve 105 towardand through the tapered channel 154 of the valve cover 150. As the heartvalve 105 is moved through the tapered channel 154, and ultimately outthrough opening 152, radial pressure provided by the tapered channel 154compresses the heart valve 105 and the heart valve 105 is converted fromits larger expanded configuration to its smaller crimped configuration.If desired, a constraint can be provided around the heart valve 105 tomaintain it in the crimped configuration and/or further crimp the heartvalve 105. The heart valve 105 can then be detached from the storagecontainer 100 and mounted to a delivery device for implantation.

Although the foregoing embodiments of the present disclosure have beendescribed in some detail by way of illustration and example for purposesof clarity and understanding, it will be apparent to those skilled inthe art that certain changes and modifications may be practiced withinthe spirit and scope of the present disclosure. It is intended that thescope of the present invention herein disclosed should not be limited bythe particular disclosed embodiments described above, but should bedetermined only by a fair reading of the claims that follow.

What is claimed is:
 1. A storage container for a prosthetic heart valve,comprising: a container housing sized to receive a heart valve in anexpanded configuration; and a crimping mechanism incorporated into thestorage container and operable to engage a heart valve and convert aheart valve from its expanded configuration to its crimpedconfiguration.
 2. The storage container of claim 1, wherein the crimpingmechanism includes a valve cover coupled to the container housing, thevalve cover including a central opening in communication with aninterior of the container housing, wherein movement of a heart valvethrough the central opening converts a heart valve from its expandedconfiguration to its crimped configuration.
 3. The storage container ofclaim 2, wherein the valve cover includes a tapered channel extendingfrom a bottom surface to the central opening, and wherein movement of aheart valve through the tapered channel converts a heart valve from itsexpanded configuration to its crimped configuration.
 4. The storagecontainer of claim 3, wherein the tapered channel defines a cone-shapedpassage.
 5. The storage container of claim 3, wherein a size of anopening to the tapered channel at the bottom surface corresponds to thesize of a heart valve in its expanded configuration.
 6. The storagecontainer of claim 2, wherein the crimping mechanism further includes: atop cover coupled to the container housing and having an opening axiallyaligned with the central opening of the valve cover; and a base having acentral cavity sized and configured to receive a heart valve, the baseaxially movable with respect to the valve cover for moving a heart valvethrough the central opening of the valve cover.
 7. The storage containerof claim 6, wherein the valve cover is fixed to the container housing.8. The storage container of claim 6, wherein the top cover is rotatablycoupled to the container housing and the valve cover.
 9. The storagecontainer of claim 8, wherein the opening of the top cover is a threadedopening, wherein the base includes an exterior thread for engaging thethreaded opening of the top cover, and wherein rotation of the top covercauses the threaded opening to engage the exterior thread of the baseand move the base axially with respect to the top cover.
 10. The storagecontainer of claim 6, wherein the crimping mechanism further includes avalve stage located within a central cavity of the base, the valve stageconfigured to provide axial support for a heart valve.
 11. The storagecontainer of claim 6, wherein the crimping mechanism further includes avalve support configured to extend axially adjacent a heart valve and toprovide radial or lateral support for a heart valve.
 12. A system forstoring and crimping an expandable prosthetic heart valve, comprising:an expandable prosthetic heart valve having both crimped and expandedconfigurations, the heart valve comprising an annular frame with aleaflet structure positioned within frame, a container housing sized toreceive the heart valve in its expanded configuration; a crimpingmechanism incorporated into the container housing and engaging the heartvalve that is operable to convert the heart valve from its expandedconfiguration to its crimped configuration.
 13. The system of claim 12,wherein the container housing holds a solution suitable for preservingthe leaflet structure.
 14. The system of claim 12, wherein the crimpingmechanism includes: a valve cover coupled to the container housing andincluding a central opening in communication with an interior of thecontainer housing; and a base having a central cavity sized andconfigured to receive the heart valve, the base axially movable withrespect to the valve cover for moving the heart valve through thecentral opening of the valve cover, wherein the heart valve ispositioned within the central cavity of the base, wherein movement ofthe heart valve through the central opening converts the heart valvefrom its expanded configuration to its crimped configuration.
 15. Thesystem of claim 14, wherein the crimping mechanism includes: a top coverrotatably coupled to the valve cover and the container housing, the topcover having an opening axially aligned with the central opening of thevalve cover.
 16. The system of claim 15, wherein the opening of the topcover is a threaded opening, wherein the base includes an exteriorthread for engaging the threaded opening of the top cover, the basebeing rotatably coupled to the top cover, and wherein rotation of thetop cover causes the threaded opening to engage the exterior thread ofthe base and move the base axially with respect to the top cover. 17.The system of claim 14, wherein the valve cover includes a taperedchannel extending from a bottom surface of the valve cover to thecentral opening of the valve cover, and wherein movement of the heartvalve through the tapered channel converts the heart valve from itsexpanded configuration to its crimped configuration.
 18. A method ofstoring and crimping an expandable prosthetic heart valve, the methodcomprising: providing a prosthetic heart valve having a crimpedconfiguration sized to be delivered to a site of implantation through acatheter and an expanded configuration sized to engage a heart valveannulus; storing the heart valve in a container in its expandedconfiguration; and converting the heart valve from its expandedconfiguration to its crimped configuration as it passes through anopening in the container.
 19. The method of claim 18, wherein the stepof converting further comprises compressing the heart valve through atapered channel provided in the container.
 20. The method of claim 19,wherein the container includes: a container housing; a valve covercoupled to the container housing and including a central opening incommunication with an interior of the container housing; and a basehaving a central cavity for receiving the heart valve, the baserotatably coupled to the valve cover and axially movable with respect tothe valve cover and container housing, wherein the step of convertingfurther comprises axially moving the base with respect to the valvecover to advance the heart valve from the central cavity of the basethrough the central opening of the valve cover.
 21. The method of claim20, wherein the container includes: a top cover rotatably coupled to thevalve cover and the container housing, the top cover having a threadedopening axially aligned with the central opening of the valve cover, thebase including an exterior thread for engaging the threaded opening ofthe top cover, wherein the step of converting further comprises rotatingthe top cover to cause the threaded opening to engage the exteriorthread of the base, thereby moving the base axially with respect to thetop cover.
 22. The method of claim 20, further maintaining the valve inits crimped state using a constraint around the valve, and detaching thevalve from the container after placing the constraint around the valveand mounting the valve on a delivery catheter.